NDC 57970-100

DALVANCE

Dalbavancin

DALVANCE is a Intravenous Injection, Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Dalbavancin Hydrochloride.

Product ID57970-100_948f52da-c121-4d45-9a8f-273ecd90a1da
NDC57970-100
Product TypeHuman Prescription Drug
Proprietary NameDALVANCE
Generic NameDalbavancin
Dosage FormInjection, Powder, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-05-23
Marketing CategoryNDA / NDA
Application NumberNDA021883
Labeler NameAllergan, Inc.
Substance NameDALBAVANCIN HYDROCHLORIDE
Active Ingredient Strength500 mg/25mL
Pharm ClassesLipoglycopeptide Antibacterial [EPC], Lipoglycopeptides [EXT]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 57970-100-01

1 VIAL in 1 PACKAGE (57970-100-01) > 25 mL in 1 VIAL
Marketing Start Date2014-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57970-100-01 [57970010001]

DALVANCE INJECTION, POWDER, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA021883
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-05-23

Drug Details

Active Ingredients

IngredientStrength
DALBAVANCIN HYDROCHLORIDE500 mg/25mL

OpenFDA Data

SPL SET ID:4b4674d8-4d1e-4728-8465-d42ada33fa5c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1539243
  • 1539248
  • Pharmacological Class

    • Lipoglycopeptide Antibacterial [EPC]
    • Lipoglycopeptides [EXT]
    • Lipoglycopeptide Antibacterial [EPC]
    • Lipoglycopeptides [EXT]

    Trademark Results [DALVANCE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DALVANCE
    DALVANCE
    85741315 4656717 Live/Registered
    ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED
    2012-09-28

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